Events

Safety Alert for Nexgen knee solution

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Zimmer Orthopedics Manufacturing Limited || Zimmer Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    R1601-01
  • Event Number
    2011DM-0007278
  • Date
    2016-01-04
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=162
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that it has detected that one of the references of the aforementioned medical device was mistakenly packaged and labeled as the other related reference, leading to potentially adverse events on patients or delays in the time of the surgical procedure.

Device

Nexgen knee solution
  • Model / Serial
    5980 and 5986, lots 62491580 and 62460315 respectively
  • Product Description
    This device is indicated for patients with severe knee pain and disability due to: • rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. • Deogenous disorders, and / or vascular necrosis of the femoral condyle. • Post-traumatic loss of joint configuration, particularly when there is a patellofemoral erosion, dysfunction or previous patellectomy. • Moderate deformitiesvalue, varus or flexion. • The rescue of unsuccessful surgical attempts previously or for a knee in which satisfactory stability can not be obtained at the moment of surgery.
  • Manufacturer
    Zimmer Orthopedics Manufacturing Limited || Zimmer Inc

Manufacturer

Zimmer Orthopedics Manufacturing Limited || Zimmer Inc
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    NIDFSINVIMA